The medical device industry produces a wide variety of electronic and mechanical devices for treating patient medical conditions such as pacemakers, defibrillators, neuro-stimulators and therapeutic substance delivery pumps. Medical devices can be configured to be surgically implanted or connected externally to the patient receiving treatment. Clinicians use medical devices alone or in combination with therapeutic substance therapies and surgery to treat patient medical conditions. For some medical conditions, medical devices provide the best and sometimes the only therapy to restore an individual to a more healthful condition and a fuller life. One type of medical device is an implantable neurological stimulation system that can be used to treat conditions such as pain, movement disorders, pelvic floor disorders, gastroparesis, and a wide variety of other medical conditions. The neurostimulation system typically includes a neurostimulator, a stimulation lead, and an extension such as shown in Medtronic, Inc. brochure “Implantable Neurostimulation System” (1998). More specifically, the neurostimulator system can be an Itrel II® Model 7424 or an Itrel 3® Model 7425 available from Medtronic, Inc. in Minneapolis, Minn. that can be used to treat conditions such as pain, movement disorders and pelvic floor disorders. The neurostimulator is typically connected to a stimulation lead that has one or more electrodes to deliver electrical stimulation to a specific location in the patient's body.
The lead and stylet combination are part of the implantable neurostimulation system. The neuro stimulation lead is placed in the desired location of the body. The stylet wire and handle combination are used to give the lead stiffness during implantation and to aid in maneuvering the lead into the desired position. Currently several types of lead and stylet combinations exist for this purpose. An example of a stylet that engages the proximal end of the lead connector region in specified locations is the Pisces Quad Lead Model 3487A stylet available from Medtronic, Inc., Minneapolis, Minn., USA. The location of the distal end of the stylet can potentially reside in different locations in the electrode region due to tolerances in both the lead and the stylet. Another combination offers a stylet that terminates at a definite point in the distal end of the lead and a handle that engages the lead at specific points at the lead proximal end. For this stylet lead combination each stylet must be custom made to fit each lead. All custom fit stylets are packaged in the lead kit. If a physician requires the use of a different stylet, a stylet from another kit may not work as intended. A third type of lead stylet system exits where the stylet terminates at a specific point in the distal end of the lead, but does not engage the lead at the proximal end. This makes maneuvering the lead more difficult. An example of a stylet handle is shown in U.S. Pat. No. 6,203,506 “Operating Device For A Stylet Unit” by Boström (Mar. 20, 2001).
Thus, embodiments of the implantable neurological stimulation lead with improved stylet handle are disclosed that improve physician stimulation lead placement control and reduce manufacturing cost.